Implantable access device for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port

ABSTRACT

An implantable access device for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port, comprising: a port body with at least one outlet opening connected or connectable to a catheter for accessing the vascular system of the human or animal body; a needle entrance with at least one inlet opening for receiving a needle, wherein the needle entrance is connected to the port body and movable relative to the port body between a first, unactuated operating condition and a second, actuated operating condition; and a flexible socket arranged between the port body and the needle entrance and at least covering the area where the needle entrance moves relative to the port body to prevent tissue growth in this area.

FIELD

The invention relates to an implantable access port for accessing thevascular system of a human or animal body, particularly subcutaneouslyimplantable access port.

BACKGROUND

During a medical treatment it is sometimes necessary to repeatedlyaccess the vascular system of a human or animal body, for example forinfusing therapeutic agents, drugs or such the like, removing bodyfluids, treating body fluids, injecting contrast agents and/or insertionof medical devices such as cameras, ultra-sound probes, brushes,catheters, catching devices or similar devices. In case of fluidexchange therapies, like for example hemodialysis, hemofiltration,hemodiafiltration, plasmapheresis, ultrafiltration, aquafiltration, nlipid pheresis, hemoperfusion, peritoneal dialysis or the like, devicesfor accessing the vascular system of a human or animal body which allowa high-volume fluid flow are preferred.

From the prior art a variety of strategies are known for accessing thevascular system of a human or animal body, like for example directvessel cannulation, short and long term catherization and implantationof subcutaneous port systems.

A temporary access to the vascular system of the human or animal bodycan be simply provided by a direct percutaneous introduction of a needlethrough the skin of the human or animal body into a vessel of thevascular system of the human or animal body. Such an approach is theleast expensive and simplest form of accessing the vascular system ofthe human or animal body and is particularly suitable for short termapplications like for example intravenous drug delivery, removal ofblood or the like. However, repeated introduction of a needle throughthe skin of the human or animal body into a vessel of the vascularsystem of the human or animal body can result in vessel thrombosis,stenosis and formation of pseudo-aneurisms, as well as infections.

Transcutaneous devices, like short and long-term catheters, are used toaddress the problems of repeated direct percutaneous introduction of aneedle through the skin of the human or animal body into a vessel of thevascular system of the human or animal body. Such transcutaneous devicescan be flexible cannulae, which are inserted percutaneously into theregion of interest such as a blood vessel or cavity in the human oranimal body. However, although transcutaneous devices deal with theproblems of a direct percutaneous introduction of a needle through theskin of the human or animal body into a vessel of the vascular system ofthe human or animal body they often cause complications due toinfections. The infection usually infects the point where the devicepasses through the skin of the human or animal body or even the vascularsystem of the human or animal body itself. Thus, such transcutaneousdevices can cause local or even systemic infections.

Therefore a direct percutaneous introduction of a needle through theskin of the human or animal body into a vessel of the vascular system ofthe human or animal body or use of a transcutaneous catheter are notwell suited for long term applications or for extracorporeal proceduresthat must be repeated periodically, like for example hemodialysis,hemofiltration, hemodiafiltration, plasmapheresis, ultrafiltration,aquafiltration, n lipid pheresis, hemoperfusion, peritoneal dialysis orthe like.

To deal with the above problems varieties of subcutaneously implantedports have been proposed over the years for long term and/orperiodically repeated accesses to the vascular system of the human oranimal body. A typical subcutaneously implanted port has an accessregion for receiving a needle or access catheter, a fluid flow paththrough the port and a subcutaneously catheter attached to a vessel ofthe vascular system of the human or animal body. Thus, a fluid flow pathis provided from the access catheter through the subcutaneouslyimplanted port and the subcutaneously catheter to the vascular system ofthe human or animal body.

The most common type of subcutaneously implanted ports, like for exampledisclosed in U.S. Pat. No. 6,056,717, comprises a housing with a portchamber for receiving an introduced needle. The surface of the portchamber next to the skin of the human or animal body is enclosed by ahigh-density self-sealing septum, typically made of silicone rubber. Asubcutaneously implanted catheter, which communicates with a vein orother site within the human or animal body, is connected and in fluidconnection to the port chamber. Implantation of such devices generallyproceeds by making a small subcutaneous pocket in an appropriate area ofthe human or animal body under local anaesthesia. The subcutaneouslyimplanted catheter is tunnelled to the desired infusion site.

Since the septum faces towards the skin of the human or animal body andthe subcutaneously implanted catheter runs substantially parallel to theskin of the human or animal body, there exists a 90° bend in the flowpath from the introduced needle, which is perpendicular to the skin ofthe human or animal body, to the subcutaneously implanted catheter.Especially for high flowrates this can result in damages to the blood,so-called hemolysis.

To avoid damaging or coring of the septum a special needle, likeso-called port or Huber needle, is introduced through the skin of thehuman or animal body and the septum into the port chamber. Damaging orcoring of the septum is avoided by a special cut of the needle. Afterthe medical treatment has been finished the needle is withdrawn from theport chamber.

Since large diameter needles can damage the rubber septum used forsealing the port chamber the fluid flow rate is limited for these knownsubcutaneously implanted port devices. Further, it is desirable to limitthe height of the subcutaneously implanted port because of opticalreason and the local stress imposed on the skin of the human or animalbody. However, this results in a limited height of the port chamber aswell as a thinner port septum; so a small displacement of the introducedneedle can cause an easier retraction of the needle out of the portchamber because of friction reduction induced by the thinner septum. Incase where toxic materials are being infused, like during chemotherapy,the retraction of the needle out of the port chamber can cause localtissue damage, which may lead to further surgical treatments likecorrective surgery or removal of tissue.

Moreover, due to the at least one 90° bend in the fluid flowing path itis difficult or even impossible to clear the subcutaneously implantedport if e.g. thrombosis occurs. A thrombus can result in serious patientinjuries like e.g. pulmonary embolism or even blockage. To clear asubcutaneously implanted port it is necessary to feed a cleaning wirethrough the hypodermic needle into the port chamber and further throughthe subcutaneously implanted catheter. However, it is very difficult tofeed the cleaning wire from the port chamber into the subcutaneouslyimplanted port due to the at least one 90° bend. In case thesubcutaneously implanted port cannot be cleaned it has to be replaced toavoid the risk of serious patient injuries.

To overcome the problems associated with the perpendicular introductionof the needle into the port chamber it has been proposed for example inDE 196 24 320 C1, EP 0 332 943 81, EP 1 629 862 A1, EP 1 765 456 81,U.S. Pat. Nos. 5,848,989 or 4,861,341 to use a tube shapedsubcutaneously implanted port, wherein the septum is arranged in such away that the needle is introduced substantially parallel to the skin ofthe human or animal body. This result in a substantially straight fluidflowing path through the subcutaneously implanted port. Due to thesubstantially straight fluid flowing path a cleaning wire or anotherdevice can be easily introduced through the port chamber into thesubcutaneously implanted catheter. Further, the length of the catheterhousing can be enhanced without causing more stress to the skin in thearea of the implantation site. Thus, the length of the port chamber canbe enhanced and the needle can be introduced further into the portchamber and thereby significantly reducing the risk of an accidentalretraction of the needle out of the port chamber.

Further, it is known from the prior art, like example from U.S. Pat.Nos. 6,007,516, 6,120,492 6,193,684 B1 and 7,056,316 B 1, to replace theseptum by a valve assembly. Due to the valve assembly fistula needlescan be introduced into the subcutaneously implanted port withoutdamaging any septum. Usually the valve is actuated by moving a part ofthe valve by the introduced needle or by advancing the introduced needlethrough the valve, like e.g. through a leaflet valve assembly. This evenallows to use larger diameter needles, which increases the maximumachievable fluid flowing rate. U.S. Pat. No. 6,565,525 B1 furtherdiscloses a dual port vascular access assembly comprising first andsecond access ports. This vascular access assembly is designed to closethe second access port in the absence of an access tube in the firstaccess port. Thus, blood withdrawal will be automatically terminatedupon cessation of blood returned to due to loss of the return accesstube in the first access port. However, according to the aforementionedprior art documents the needles are introduced perpendicular to the skinof the human or animal body and thus, they still suffer from theabove-mentioned problems associated with the perpendicular introductionof the needle into the port chamber.

U.S. Pat. No. 5,350,360, EP 1 016 431 A1, U.S. Pat. Nos. 5,741,228,5,356,381 and 5,352,204 each disclose a subcutaneously implantableaccess port with a housing having a funnel shaped inlet orifice leadingto a reduced diameter guide passageway. An articulating valve, which maytake various forms including leaflet type valves or self-collapsingtubular valves, are placed in line with the access port housing. Anexternal filament such as a needle, guide wire, optical fibre, orexternal catheter can be introduced into the access device and fedthrough the housing to penetrate the articulating valve.

U.S. Pat. Nos. 5,911,706 and 6,506,182 B2 each disclose an implantablesingle or dual-lumen device for repeated accessing vessels within ahuman or animal body. The device uses a resilient material to form aseal and has a smooth streamlined flowpath with no flow discontinuity.The device is joined to a subcutaneously implanted catheter, such thatfluids can be extracted from or injected into the vessel to be accessed.The device is designed for the high flowrates, on the order of 150 andgreater millilitres per minute, associated with fluid exchangetherapies. A smooth flow streaming is important to minimize damage tothe blood. A corresponding straight-needle apparatus is designed to mateand lock with the access device, where alignment and open flowpath isensured. A valve seal incorporates opposing very hard surfaced guideelements that are retained and in intimate contact with the seal itself.The needle assembly pushes open these guide elements which open the sealbefore the needle point reaches the seal material.

Especially in case of fluid exchange therapies, like for examplehemodialysis, hemofiltration, hemodiafiltration, plasmapheresis,ultrafiltration, aquafiltration, n lipid pheresis, hemoperfusion,peritoneal dialysis or the like, which require a high-volume fluid flowthere is a need of devices for accessing the vascular system of a humanor animal body which guarantee that the maximum fluid flow rate isachieved. Further, since fluid exchange therapies usually need more thanone hour the device for accessing the vascular system together with theinserted needle should be as comfortable as possible for the patient,i.e. have a low profile and be as close as possible to the skin of thepatient.

SUMMARY

These objects are solved according to the invention by an implantableaccess device for accessing the vascular system of a human or animalbody, particularly subcutaneously implantable access port, comprising:

a port body with at least one outlet opening connected or connectable toa catheter for accessing the vascular system of the human or animalbody,

a needle entrance with at least one inlet opening for receiving aneedle, wherein the needle entrance is connected to the port body andmovable relative to the port body between a first, unactuated operatingcondition and a second, actuated operating condition, and

locking means for locking the needle entrance in the first, unactuatedoperating condition and in the second, actuated operating condition,wherein the locking means are activated by inserting the needle into theneedle entrance and applying a predetermined movement to needle entrancevia the inserted needle and/or by applying a predetermined movement tothe needle entrance via the inserted needle and removing the needle fromthe needle entrance.

According to the invention the passageway through the implantable accessdevice, i.e. from the inserted needle, through the port body andcatheter attached to the outlet opening of the port body, is completelyclosed in the first, unactuated operating condition and completelyopened in the second, actuated operating condition. Therefore, forexample the port body comprises a valve mechanism which is actuated,i.e. opened and closed, by the relative movement of the needle entranceto the port body.

Since the locking means of the inventive implantable access device areactivated by inserting the needle into the needle entrance the insertedneedle can be moved closer to the skin of the patient by the relativemovement of the needle entrance with the inserted needle to the portbody. Thus, in the second, activated operating condition the needleinserted in the needle entrance has moved closer to the skin of thepatient and thereby enhancing the comfort during the medical treatment.

Since the locking means are locked in the first, unactuated operatingcondition respectively the second, actuated operating condition it isguaranteed that the passageway through the inventive implantable accessdevice is either completely closed or completely opened. Thus, thelocking means have two stable operating conditions, so-called bi-stablemechanism.

According to a variant of the invention the implantable access devicefurther comprises blocking means which block a relative movement of theneedle entrance to the port body in case no needle has been insertedinto the needle entrance. Thus, an accidental actuation of theimplantable access device, i.e. movement of the needle entrance from thefirst, unactuated operating condition to the second, actuated operatingcondition is prevented.

In a preferred variant of the invention the predetermined movement ofthe needle entrance at least partially differs from the movement of theneedle for inserting the needle into the needle entrance. Thus, themovement of inserting the needle into the needle entrance alone cannotactuated the implantable access device, i.e. move the needle entrancefrom the first, unactuated operating condition to the second, actuatedoperating condition. For such an actuation the person who inserted theneedle into the needle entrance of the implantable access device must atleast partially change the movement. In this way an accidental actuationduring insertion of the needle into the needle entrance is prevented.

Pursuant to an advantageous variant of the invention the predeterminedmovement of the needle entrance comprises a pivoting and/ortranslational movement of the needle entrance. Preferably thepredetermined movement of the needle entrance comprises a pivoting andtranslational movement. For example, first the needle entrance must beslightly moved translational to enable a pivoting movement and after thepivoting movement the needle entrance is locked in the other operatingcondition by another translational movement. Thus, first the operatingcondition is unlocked by a translational movement, then the needleentrance and the needle therein is pivoted closed to the skin of thepatient and afterwards the needle entrance is locked in the otheroperating condition by another translational movement.

In a variant of the invention the insertion angle of the needleentrance, in which the needle is inserted into the needle entrance, isbetween 15° and 40°, preferably between 25° and 30°. In this range it iseasy to insert the needle into the needle entrance and to provide astreamlined flowpath through the implantable access device and toconform the inserted needle close to the skin of the patient in thesecond, actuated operating condition.

In a further preferred variant, the needle entrance comprises a funnelto guide the needle into the needle entrance.

According to variant of the invention the locking means comprise a camon the needle entrance and a corresponding recess for guiding the cam onthe port body and/or a cam on the port body and a corresponding recessfor guiding the cam on the needle entrance. Using such cam and recessmeans the relative movement between the needle entrance and the portbody can be defined and guided.

Pursuant to a preferred variant of the invention the cam is shapedrectangular or triangular, preferably with rounded corners. Arectangular or triangular cam is easy to manufacture by e.g. injectionmolding or such the like and provided a good stability. The roundedcorners avoid blocking or jamming of the cam in the recess for guidingthe cam.

According to a variant of the invention the recess has at least one,preferably two, pits for receiving the cam either in the first,unactuated operating condition or in the second, actuated operatingcondition. Thus, the cam can be locked in the first and/or secondoperating condition by moving the cam in the pit of the recess. A recessfor guiding the cam with two recesses is according to a preferredvariant of the invention heart shaped.

In a preferred embodiment of the invention the locking means comprise aballpoint pen mechanism or a SD-slot mechanism for locking the needleentrance in the first, unactuated operating condition and in the second,actuated operating condition. Alternatively, the locking means comprisea snap fit connection, preferably a snap on the needle entrance and atleast one recess or protrusion on the port body for receiving orengaging with the snap, for locking the needle entrance in the first,unactuated operating condition and in the second, actuated operatingcondition. Such mechanisms are generally referred to aspush-push-locking mechanisms and are known from the prior art in manydifferent designs, like e.g. DE809514, DE812404, DE1267570, U.S. Pat.No. 6,454,170, for several decades.

According to a preferred variant of the invention the locking meanscomprise a spring for locking the locking means in the first, unactuatedoperating condition and in the second, actuated operating condition.Thus, bi-stable system is achieved and only a partial opening of thepassageway through the implantable access port is avoided. This isparticularly advantageous for fluid exchange therapies which require ahigh flowrate.

In a particularly preferred variant the spring is connected to orintegrally formed with the valve mechanism of the implantable accessdevice. Thus, the first unactuated operating condition of the needleentrance is directly connected to the first, unactuated operatingcondition of the valve mechanism and the second, actuated operatingcondition of the needle entrance is directly connected to the second,actuated operating condition of the valve mechanism.

According to a particular advantageous variant of the invention thelocking means create an audio and/or haptic feedback, like a soundand/or vibration, when being locked in the first, unactuated operatingcondition and/or in the second, actuated operating condition.

As described above it is advantageous to have an implantable accessdevice for accessing the vascular system of a human or animal body,particularly subcutaneously implantable access port, comprising:

a port body with at least one outlet opening connected or connectable toa catheter for accessing the vascular system of the human or animalbody, and

a needle entrance with at least one inlet opening for receiving aneedle, wherein the needle entrance is connected to the port body andmovable relative to the port body between a first, unactuated operatingcondition and a second, actuated operating condition.

One problem associated with needle entrance that is movable relative tothe port body between a first, unactuated operating condition and asecond, actuated operating condition is that the tissue surrounding theimplantable access device can be pinched during the relative movementbetween the needle entrance and the port body, which can be unpleasantfor the patient. Further, the tissue surrounding the implantable accessdevice can block the relative movement between the needle entrance andthe port body.

It is thus an object of the present invention to provide an implantableaccess device for accessing the vascular system of a human or animalbody, particularly subcutaneously implantable access port, comprising aport body with at least one outlet opening connected or connectable to acatheter for accessing the vascular system of the human or animal body,and a needle entrance with at least one inlet opening for receiving aneedle, wherein the needle entrance is connected to the port body andmovable relative to the port body between a first, unactuated operatingcondition and a second, actuated operating condition that avoids theaforementioned problems.

According to the present invention the object is solved in that theimplantable access device for accessing the vascular system of a humanor animal body, particularly subcutaneously implantable access port,further comprises a flexible socket arranged between the port body andthe needle entrance and at least covering the area or volume where theneedle entrance moves relative to the port body to prevent tissue growthin this area. Since the area or volume where a relative movement betweenneedle entrance and the port body takes place is covered by the flexiblesocket a pinching of tissue is avoided. Further, no tissue can grow inthis area because it is already covered by the flexible socket.

The flexible socket is designed such that the flexible socket isdeformed by the relative movement between needle entrance and the portbody. By this deformation of the flexible socket the surrounding tissuewill be pushed out of the moving path and thereby avoiding any pinchingof tissue. According to the invention the flexible socket can be atleast deformed in such a way that the flexible socket has no negativeimpact on the relative movement between the needle entrance and the portbody, i.e. the complete desired relative movement between the needleentrance and the port body is possible.

According to a variant of the present invention the flexible socket hasa first opening for connecting the flexible socket to the port body anda second opening for connecting the flexible socket to the needleentrance. The two openings of the flexible socket allow an easy assemblyof the implantable access device for accessing the vascular system of ahuman or animal body, particularly subcutaneously implantable accessport, comprising a port body and a needle entrance, wherein the needleentrance is connected to the port body and movable relative to the portbody between a first, unactuated operating condition and a second,actuated operating condition.

In a further variant of the invention the flexible socket is hollow. Aflexible and hollow socket has the advantage that the socket can beeasily deformed during the relative movement of the needle entrance tothe port body and at the same time prevents any pinching of tissueand/or tissue growth between the needle entrance and the port,especially in the area or volume of relative movement between these twoparts. Further, this saves material costs during manufacturing.

In a preferred variant of the invention the first opening of theflexible socket is smaller than a corresponding portion of the portbody, where the first opening of the flexible socket is connected to theport body. Since the socket is flexible and the first opening is smallerthan the connecting portion of port body the first opening of theflexible socket is stretched during the connection to the connectingportion of the port body. This stretching of the first opening of theflexible socket creates a friction-force based connection between theflexible socket, particularly the first opening of the flexible socket,and the connecting portion of the port body. For example, the firstopening of the flexible socket is about 10 to about 20% smaller than theconnecting portion of the port body. This creates a sufficientconnection between the first opening of the flexible socket and theconnecting portion of the port body without any risk of damaging thefirst opening of the flexible socket due to overstretching. Further,such a first opening of the flexible socket provides a good sealingbetween the port body and the flexible socket.

According to a preferred variant of the invention the first opening ofthe flexible socket and the connecting portion of the port body havecorresponding surfaces. The corresponding surfaces of the first openingof the flexible socket and the connecting portion of the port body havethe advantage that the contact surface between the first opening of theflexible socket and the connecting portion of the port body is enhancedand thereby enhancing the friction force between the first opening ofthe flexible socket and the connecting portion of the port body.

In a particularly preferred variant of the invention the correspondingsurfaces comprise protrusions and recesses, like a barbed fit. Such abarb fit allows an easy movement of the first opening of the flexiblesocket to the connecting portion of the port body in the assemblydirection and prevents a movement of the flexible socket to theconnecting portion of the port body in the opposite direction.

In an alternative variant of the invention the flexible socket,particularly the first opening of the flexible socket, is connected tothe port body by clamping at least a part of the flexible socket betweentwo corresponding parts of the port body. If the port body consists ofat least two parts the flexible socket can be safely connected to theport body during manufacturing by clamping at a part of the flexiblesocket between the at least two parts of the port body. This alsoprovides a good sealing between the port body and the flexible socket.

According to a variant of the invention the implantable access devicefurther comprises a receptacle movably connected to the port body andwherein the needle entrance can be connected to the receptacle, so thatthe receptacle and the needle entrance are movable relative to the portbody. In this variant the flexible socket at least covers the area orvolume where the needle entrance and the receptacle move relative to theport body to prevent tissue growth in this area.

In a variant of the invention at least a part, preferably the secondopening, of the flexible socket is clamped between correspondingsurfaces of the receptacle and the needle entrance. In this way theflexible socket, particularly the second opening of the flexible socket,is securely connected to the implantable access device and any tissuegrowth in the area or volume of relative movement between the needleentrance and the receptacle to the port body is prevented. Further, thisclamping of the flexible socket, especially the second opening of theflexible socket, between the receptacle and the needle entrance can beeasily achieved during assembly of the inventive implantable accessdevice.

In a further variant the flexible socket at least partially consists ofsilicone. A flexible silicone socket provides all the above-mentionedadvantages and at the same time is easy and cheap to manufacture.

The invention further relates to a flexible socket that is configuredand/or designed to be used with an implantable access device accordingto the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be further explained with respect toembodiments shown in the figures, wherein:

FIG. 1a shows a perspective view of an implantable access device in afirst, unactuated operating condition;

FIG. 1b shows the implantable access device from FIG. 1a in a second,actuated operating condition;

FIG. 2 shows a cross-sectional view of an implantable access device witha movable needle entrance and a first embodiment of locking means;

FIG. 3a, 3b show a cross-sectional view of an implantable access devicewith a movable needle entrance and a second embodiment of locking means;

FIG. 4a-4d show a third embodiment of locking means for an implantableaccess device;

FIG. 5a, 5b show a fourth embodiment of locking means for an implantableaccess device;

FIG. 6a, 6b show a fifth embodiment of locking means for an implantableaccess device;

FIG. 7 shows the implantable access device from FIG. 1a with tissuegrowth;

FIG. 8a shows a cross-sectional view of an implantable access devicewith a flexible socket in a first, unactuated operating condition;

FIG. 8b shows a cross-sectional view of the implantable access devicefrom FIG. 8a in a second, actuated operating condition;

FIG. 9 shows a detailed view of a barb connection between a flexiblesocket and a port body;

FIG. 10a shows a detailed view of a needle entrance and a receptacle;and

FIG. 10b shows a detailed cross-sectional view of a flexible socketclamped between a needle entrance and a receptacle.

DETAILED DESCRIPTION

FIG. 1a shows a perspective view of an implantable access 1 foraccessing the vascular system of a human or animal body, particularlysubcutaneously implantable access port, in a first, unactuated operatingcondition. The implantable access device 1 comprises a port body 2 withat least one outlet opening connected or connectable to a catheter foraccessing the vascular system of the human or animal body. Theimplantable access device 1 further comprises a needle entrance 3 withat least one inlet opening for receiving a needle. The needle entrance 3is connected to the port body 2 via a receptacle 4. The needle entrance3 and the receptacle 4 are movable relative to the port body 2 between afirst, unactuated operating condition as shown in FIG. 1a and a second,actuated operating condition as shown in FIG. 1 b.

In the first, unactuated operating condition the passageway through theimplantable access port 1 is closed. Once a needle has been introducedinto the needle entrance 3 the needle entrance 3 and the receptacle 4are moved relative to the port body 2 from the first, unactuatedoperating condition into the second, actuated operating condition. Inthe second, actuated operating condition the passageway through theimplantable access port 1 is opened and a fluid flow, in principle inboth flow directions, through the needle and the implantable access port1 is enabled. Furthermore, in the second, actuated operating conditionthe needle inserted into the needle entrance 3 is fixed in the needleentrance 2, for example by a friction force. After the treatment hasbeen finished, the needle entrance 3 and the receptacle 4 are movedrelative to the port body 2 from the second, actuated operatingcondition to the first, unactuated operating condition, thereby closingthe passageway through the implantable access port 1 and at the sametime releasing the needle from the needle entrance 3.

Preferably the needle entrance 3 and/or the receptacle 4 are pivotablerelative to the port body 2 from the first, unactuated operatingcondition to the second, actuated operating condition. Further, in avariant of the invention it is possible that the needle entrance 3and/or receptacle 4 can be fixed in the second, actuated operatingcondition by a translational movement of the needle entrance 3 and/orthe receptacle 4 relative to the port body 2.

FIG. 2 shows a cross-sectional view of an implantable access device 1for accessing the vascular system of a human or animal body,particularly subcutaneously implantable access port. The implantableaccess device 1 of FIG. 2 comprises a port body 2 with at least oneoutlet opening 11 connected or connectable to a catheter for accessingthe vascular system of the human or animal body. The implantable accessdevice further comprises a needle entrance 3 with at least one inletopening 9 for receiving a needle, wherein the needle entrance 3 isconnected to the port body and movable relative to the port body 2between a first, unactuated operating condition and a second, actuatedoperating condition.

In the first, unactuated operating condition the passageway 10 from theinlet opening 9 of the needle entrance 3 to the outlet opening 11 of theport body 2 is closed by a valve 12 and in the second, actuatedoperating condition the passageway 10 from the inlet opening 9 of theneedle entrance 3 to the outlet opening 11 of the port body 2 is openedby the valve 12.

The implantable access device 1 of FIG. 2 further comprises lockingmeans 8 for locking the needle entrance 3 in the first, unactuatedoperating condition and in the second, actuated operating condition. Thelocking means 8 are activated by inserting the needle into the needleentrance 3 and applying a predetermined movement to the needle entrance3 via the inserted needle and/or by applying a predetermined movement tothe needle entrance 3 via the inserted needle and removing the needlefrom the needle entrance 3.

The locking means 8 shown in FIG. 2 first require a translationalmovement of the needle entrance 3 to the port body 2 and afterwards apivoting movement of the needle entrance 3 to the port body 2 fortransferring the needle entrance 3 from the first, unactuated operatingcondition to the second, actuated operating condition. For transferringthe needle entrance 3 from the second, actuated operating condition backto the first, unactuated operating condition first a pivoting movementof the needle entrance 3 to the port body 2 followed by a translationalmovement of the needle entrance 3 to the port body 2 is necessary. Sincethe insertion of the needle into the needle opening 9 of the needleentrance 3 requires a diagonal movement of the needle the predeterminedmovement of the needle entrance 3 at least partially differs from themovement of the needle for inserting the needle into the needle entrance3.

The needle entrance 3 comprises a funnel 13 for guiding the needle intothe inlet opening 9 of the needle entrance.

The locking means 8 shown in FIG. 2 are implemented by a recess in theport body 2 into which a part of the needle entrance 3 engages in thefirst, unactuated operating condition. Further, the needle entrance 3 ispivotable in the port body 2 unless the part of the needle entrance 3engages in the recess of the port body 2. Thus, for moving the needleentrance 3 from the first, unactuated operating condition to the second,actuated operating condition the part of the needle entrance 2 is firstretracted from the recess of the port body 2 by a translational movementand afterwards the needle entrance 3 is pivoted relative to the portbody 2. For moving the needle entrance 3 from the second, actuatedoperating condition to the first, unactuated operating condition theneedle entrance 3 is first pivoted relative to the port body 2 andafterwards the part of the needle entrance 3 is moved into the recess ofthe port body 2 by a translational movement.

The locking in the first, unactuated operating condition is achieved byarranging the part of the needle entrance 3 in the recess of the portbody 2. In the second, actuated operating condition the locking isachieved by a friction force between party of the needle entrance 3 andthe inner surface of the port body 2.

The movement from the second, actuated operating condition to the first,unactuated operating condition can be supported by a spring between theport body 2 and the needle entrance 3. Preferably the spring isconnected to or integrally formed with the valve mechanism 12 of theimplantable access device 1.

FIGS. 3a and 3b show cross-sectional views of an implantable accessdevice 1 with a movable needle entrance 3 and a second embodiment oflocking means 8. The locking 8 according to the second embodiment ofshown in FIGS. 3a and 3b differs from the first embodiment mainly inthat not pivoting movement of the needle entrance 3 is necessary fortransferring the needle entrance 3 from the first, unactuated operatingcondition to the second, actuated operating condition. However, still inthe first, unactuated operating condition a part of the needle entranceengages into a recess of the port body 2, as shown in the front part ofthe implantable access device at the left side of FIG. 3 a.

FIG. 3b is a cross-sectional view of the implantable access device 1from FIG. 3a outside of the middle of the port body, especially close tothe side wall of the port body 2.

As can be seen from FIG. 3b the locking means according to the secondembodiment further comprise a cam 14 on the needle entrance 3 and acorresponding recess 15 for receiving the cam 14 on the port body 2. Inthe second, actuated operating condition the cam 14 of the needleentrance 3 is received in the recess 15 of the port body 2 for lockingthe needle entrance 3 in the second, actuated operating condition.

The movement from the second, actuated operating condition to the first,unactuated operating condition can be supported by a spring between theport body 2 and the needle entrance 3. Preferably the spring isconnected to or integrally formed with the valve mechanism 12 of theimplantable access device 1.

The embodiment shown in FIGS. 3a and 3b further differs from theembodiment shown in FIG. 2 in that the overall design is flatter andstream lined. Especially the insertion angle in which the needle isinserted into the needle entrance 3 is smaller. Preferably the insertionangle of the needle entrance 3, in which the needle is inserted into theneedle entrance 3, is between 15° and 40°, preferably between 25° and30°.

FIG. 4a shows a needle entrance 3 for an implantable access device 1. Oneach side wall of the needle entrance a snap-fit 16 is arranged. FIG. 4bshows a detailed view of this snap-fit 16. The snap-fit 16 has aflexible part 18 and a hook part 19. The hook part 19 protrudes over theside wall of the needle entrance 3.

FIG. 4c shows a port body 2 for receiving the needle entrance 3 of FIG.4a . The port body 2 comprises a protrusion 17 on each side wall. Thesnap-fit 16, particularly the hook 19 of the snap-fit 16 engages withthe protrusion 17 in the second, actuated operating condition.

FIG. 4d shows an implantable access device 1 comprising a needleentrance 3 according to FIG. 4a and a port body 2 according to FIG. 4c .Other parts of the implantable access device 1, like e.g. the valve 12between the port body 2 and the needle entrance 3 have been omitted dueto simplicity. FIG. 4d shows the implantable access device in the first,unactuated operating condition. For moving the needle entrance 3 intothe second, actuated operating condition the needle entrance is movedtranslational towards the outlet 11 of the port body. Thereby the valve12 located between the port body 2 and the needle entrance 3 would beactuated and the passageway through the implantable access device 1would be opened. The needle entrance 3 is moved so far towards theoutlet 11 that the hooks 19 engage with the protrusions 17 of the portbody 2. This is possible due to the flexible parts 18 of the snap-fit16.

As can be seen from FIG. 4c or FIG. 4d the protrusion does not cover thetotal height of the port body 2 but ends above the base portion of theport body 2. By pivoting the needle entrance 3 it is possible todisengage the hooks 19 of the snap-fit 16 with the protrusions 17 of theport body 2, so that the needle entrance 3 can move back from thesecond, actuated operating condition to the first, actuated operatingcondition. This movement can be supported by a spring between the portbody 2 and the needle entrance 3. Preferably the spring is connected toor integrally formed with the valve mechanism 12 of the implantableaccess device 1.

FIG. 5a shows a partial cross-sectional view of a fourth embodiment oflocking means 8 for an implantable access device 1 comprising a portbody 2 and a movable needle entrance 3. The main difference to the thirdembodiment of FIG. 4 is that the the snap-fits 16 have been arranged onthe upper and lower sides of the needle entrance 3 and the protrusion ofthe port body 2 has been replaced by a recess 15 on the upper wall ofthe port body 2.

FIG. 5b shows a detailed view of the snap-fit 16 of FIG. 5a in thesecond, actuated operating condition. In this second, actuated operatingcondition the hook 19 of the snap-fit 16 engages into the recess 15 ofthe port body. 2. By pivoting the needle entrance 3 the hook 19 can beretracted from the recess 15 and the needle entrance can be transferredto the first, unactuated operating condition.

The lower wall of the port body 2 can comprise a further recess 15 forthe lower snap-fit 16 in the first, unactuated operating condition,although this is not necessary. The lower snap-fit 16 has the mainfunction to force the hook of the upper snap-fit 16 into the recess 15in the second, actuated operating condition.

FIG. 6a shows a needle entrance 3 for a fifth embodiment of a lockingdevice 9 for an implantable access device 1. The needle entrance 3comprises a cam 14 on each side wall. The cam 14 is triangular shaped,with rounded corners for s smooth relative movement between the needleentrance 2 and a port body 2, as shown e.g. in FIG. 6 b.

The port body 2 shown in FIG. 6b comprises in each side wall a recess 15for guiding the cam 14 of the needle entrance 3. In the first,unactuated operating condition the pointed end of the triangular shapedcam 14 is arranged in the pit 20 of recess 15. Thereby the needleentrance 3 is locked in the first, unactuated operating condition.

To transfer the needle entrance 3 into the second, actuated operatingcondition the needle entrance 3 is first moved translational until thepointed end of the triangular cam 14 is outside of pit 20. Afterwards,the needle entrance is pivoted into the second, actuated operatingcondition. In this second, actuated operating condition the needleentrance 3 is locked by a friction force between the cam 14 and the sidewall of recess 15.

Alternatively, the recess 15 can comprise a further pit 20 for lockingthe cam in the second, actuated operating condition by a furthertranslational movement, so that the pointed end of the triangular cam 14is arranged in the second pit 20. In this embodiment the recess 15 isshaped like a heart.

The aforementioned locking means 8 are only illustrative and the skilledperson can combine features of the different described locking means 8with each other or can implement other locking means into theimplantable access device within the scope of this invention. Ingeneral, every bistable locking means 8 can be used with an implantableaccess device 1, including a ballpoint pen mechanism or a SD-slotmechanism. Preferably push-push locking means 8 are used, with atranslational and/or pivoting movement for actuation.

FIG. 7 shows a detailed view of the implantable access device 1 fromFIG. 1a in the area or volume of the movement between the needleentrance 3 with the receptacle 4 to the port body 2. As has beenindicated by numeral 5 tissue has started to grow into the area orvolume where the movement between the needle entrance 3 with thereceptacle 4 and the port body 4 takes place. This tissue 5 would bepinched by pivoting the needle entrance 3 with the receptacle 4 relativeto the port body 2 to the second, actuated operating condition as shownFIG. 1b and thereby eventually causing pain to the patient and/orblocking the relative movement between the needle entrance 3 with thereceptacle 4 to the port body 2.

FIG. 8a shows a cross-sectional view an implantable access device 1 witha flexible socket 6 in a first, unactuated operating condition. Theflexible socket 6 is arranged between the needle entrance 3 with thereceptacle 4 and the port body 2. The flexible socket 6 at least coversthe area or volume where the needle entrance 3 and the receptacle 4 moverelative to the port body 2 to prevent tissue growth in this area orvolume, as indicated by numeral 5 in FIG. 8a outside the flexible socket6. As can be seen from the cross-sectional view of FIG. 8a the flexiblesocket 6 is hollow.

Preferably the flexible socket 6 has a first opening for connecting theflexible socket 6 to the port body 2 and a second opening for connectingthe flexible socket 6 to the needle entrance 3 and/or receptacle 4.

For a secure fixing of the flexible socket 6 to the port body 2 thefirst opening of the flexible socket 6 is smaller, e.g. 10% to 20%smaller, than a corresponding connecting portion of the port body 2.

The second opening of the flexible socket 6 is for example clampedbetween the needle entrance 3 and the receptacle 4, as will be explainedlater with respect to FIGS. 10a and 10 b.

Preferably the flexible socket 6 is made of silicone.

FIG. 8b shows the implantable access device of FIG. 8a in a second,actuated operating condition. In the shown second, actuated operatingcondition the needle entrance 3 with the receptacle 4 have been pivotedrelative to the port body 2, thereby deforming the flexible socket 6.The deformed flexible socket 6 pushes the surrounding tissue away fromthe implantable access device 1, especially in the area or volume ofrelative movement between the needle entrance 3 with receptacle 4 andthe port body 2.

FIG. 9 shows a detailed view of a barb connection 7 between a flexiblesocket 6 and a port body 2. The flexible socket 6, particularly thefirst opening of the flexible socket 6, and the connecting portion ofthe port body 2 have corresponding surfaces, so that the contact areaand thus, the fixing is enhanced. Particularly preferred thecorresponding surfaces comprise protrusions and recesses, like the barbconnection 7 shown in FIG. 9. The shown barb connection 7 has theadditional advantage that only a movement of the flexible socket 6 tothe port body 2 in the assembly direction is possible, where a movementin the opposite direction is prevented by the barb connection 7.

FIG. 10a shows a detailed view of a needle entrance 3 and a receptacle4. The needle entrance 3 and the receptacle 4 are designed such that theneedle entrance 3 can be introduced and fixed inside the receptacle 4.The receptacle 4 is movably connected to the port body 2 of theimplantable access device 1, to define the relative movement between theneedle entrance 3 with the receptacle 4 and the port body 2 from thefirst, unactuated operating condition to the second, actuated operatingcondition.

FIG. 10b shows a detailed view of the needle entrance 3 introduced intothe receptacle 4 of FIG. 10a . Between the needle entrance 3 and thereceptacle 4 the flexible socket 6 has been at least partially,preferably the second opening of the flexible socket 6, clamped, to fixthe flexible socket 6 to the needle entrance 3 and receptacle 4.

LIST OF NUMERALS

-   1 implantable access device-   2 port body-   3 needle entrance-   4 receptacle-   5 tissue-   6 flexible socket-   7 barb connection-   8 locking means-   9 inlet opening-   10 passageway-   11 outlet opening-   12 valve-   13 funnel-   14 cam-   15 recess-   16 snap-fit-   17 protrusion-   18 flexible part-   19 hook-   20 pit

What is claimed is: 1-11. (canceled)
 12. An implantable access device toaccess a vascular system of a human or animal body, particularly asubcutaneously implantable access port, comprising: a port body with atleast one outlet opening connected or connectable to a catheter toaccess the vascular system of the human or animal body; a needleentrance with at least one inlet opening to receive a needle, whereinthe needle entrance is connected to the port body and movable relativeto the port body between a first, unactuated operating condition and asecond, actuated operating condition; and a flexible socket arrangedbetween the port body and the needle entrance and at least covering anarea or volume where the needle entrance moves relative to the port bodyto prevent tissue growth in the area or volume where the needle entrancemoves relative to the port body.
 13. The implantable access deviceaccording to claim 12, wherein the flexible socket is hollow.
 14. Theimplantable access device according to claim 12, wherein the flexiblesocket has a first opening to connect the flexible socket to the portbody and a second opening to connect the flexible socket to the needleentrance.
 15. The implantable access device according to claim 14,wherein the flexible socket is hollow.
 16. The implantable access deviceaccording to claim 14, wherein the first opening of the flexible socketis smaller than a connecting portion of the port body, where the firstopening of the flexible socket is connected to the port body.
 17. Theimplantable access device according to claim 16, wherein the firstopening of the flexible socket and the connecting portion of the portbody have corresponding surfaces.
 18. The implantable access deviceaccording to claim 17, wherein the corresponding surfaces comprise atleast one protrusion and at least one recess, wherein the at least oneprotrusion is disposed in the at least one recess.
 19. The implantableaccess device according to claim 18, wherein the at least one protrusiondisposed in the at least one recess forms a barbed connection.
 20. Theimplantable access device according to claim 12, wherein at least a partof the flexible socket is connected to the port body by clamping betweentwo corresponding parts of the port body.
 21. The implantable accessdevice according to claim 12, further comprising a receptacle movablyconnected to the port body and wherein the needle entrance isconnectable to the receptacle, such that the receptacle and the needleentrance are movable relative to the port body.
 22. The implantableaccess device according to claim 21, wherein at least a part of theflexible socket is clamped between corresponding surfaces of thereceptacle and the needle entrance.
 23. The implantable access deviceaccording to claim 22, wherein the flexible socket has a first openingto connect the flexible socket to the port body and a second opening toconnect the flexible socket to the needle entrance, and wherein thesecond opening of the flexible socket is clamped between thecorresponding surfaces of the receptacle and the needle entrance. 24.The implantable access device according to claim 12, wherein theflexible socket comprises rubber.
 25. The implantable access deviceaccording to claim 12, wherein the flexible socket comprises silicone.26. A flexible socket arranged between a port body and a needle entranceof a subcutaneously implantable access port, wherein the port body andthe needle entrance are movable relative to one another, and wherein theflexible socket at least covers an area or volume where the needleentrance moves relative to the port body, such that tissue growth in thearea or volume where the needle entrance moves relative to the port bodyis prevented when the subcutaneously implantable access port isimplanted in a human or animal body.